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From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision t...

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Autores principales: Thurin, Nicolas H., Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach‐Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase‐Michel, Christine, Beau, Anna‐Belle, Droz‐Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero‐Carbonell, Clara, Barrachina‐Bonet, Laia, Gomez‐Lumbreras, Ainhoa, Giner‐Soriano, Maria, Aragón, María, Neville, Amanda J., Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K., Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E., Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299060/
https://www.ncbi.nlm.nih.gov/pubmed/34826340
http://dx.doi.org/10.1002/cpt.2476
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author Thurin, Nicolas H.
Pajouheshnia, Romin
Roberto, Giuseppe
Dodd, Caitlin
Hyeraci, Giulia
Bartolini, Claudia
Paoletti, Olga
Nordeng, Hedvig
Wallach‐Kildemoes, Helle
Ehrenstein, Vera
Dudukina, Elena
MacDonald, Thomas
De Paoli, Giorgia
Loane, Maria
Damase‐Michel, Christine
Beau, Anna‐Belle
Droz‐Perroteau, Cécile
Lassalle, Régis
Bergman, Jorieke
Swart, Karin
Schink, Tania
Cavero‐Carbonell, Clara
Barrachina‐Bonet, Laia
Gomez‐Lumbreras, Ainhoa
Giner‐Soriano, Maria
Aragón, María
Neville, Amanda J.
Puccini, Aurora
Pierini, Anna
Ientile, Valentina
Trifirò, Gianluca
Rissmann, Anke
Leinonen, Maarit K.
Martikainen, Visa
Jordan, Sue
Thayer, Daniel
Scanlon, Ieuan
Georgiou, Mary E.
Cunnington, Marianne
Swertz, Morris
Sturkenboom, Miriam
Gini, Rosa
author_facet Thurin, Nicolas H.
Pajouheshnia, Romin
Roberto, Giuseppe
Dodd, Caitlin
Hyeraci, Giulia
Bartolini, Claudia
Paoletti, Olga
Nordeng, Hedvig
Wallach‐Kildemoes, Helle
Ehrenstein, Vera
Dudukina, Elena
MacDonald, Thomas
De Paoli, Giorgia
Loane, Maria
Damase‐Michel, Christine
Beau, Anna‐Belle
Droz‐Perroteau, Cécile
Lassalle, Régis
Bergman, Jorieke
Swart, Karin
Schink, Tania
Cavero‐Carbonell, Clara
Barrachina‐Bonet, Laia
Gomez‐Lumbreras, Ainhoa
Giner‐Soriano, Maria
Aragón, María
Neville, Amanda J.
Puccini, Aurora
Pierini, Anna
Ientile, Valentina
Trifirò, Gianluca
Rissmann, Anke
Leinonen, Maarit K.
Martikainen, Visa
Jordan, Sue
Thayer, Daniel
Scanlon, Ieuan
Georgiou, Mary E.
Cunnington, Marianne
Swertz, Morris
Sturkenboom, Miriam
Gini, Rosa
author_sort Thurin, Nicolas H.
collection PubMed
description In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother‐child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population.
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spelling pubmed-92990602022-07-22 From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding Thurin, Nicolas H. Pajouheshnia, Romin Roberto, Giuseppe Dodd, Caitlin Hyeraci, Giulia Bartolini, Claudia Paoletti, Olga Nordeng, Hedvig Wallach‐Kildemoes, Helle Ehrenstein, Vera Dudukina, Elena MacDonald, Thomas De Paoli, Giorgia Loane, Maria Damase‐Michel, Christine Beau, Anna‐Belle Droz‐Perroteau, Cécile Lassalle, Régis Bergman, Jorieke Swart, Karin Schink, Tania Cavero‐Carbonell, Clara Barrachina‐Bonet, Laia Gomez‐Lumbreras, Ainhoa Giner‐Soriano, Maria Aragón, María Neville, Amanda J. Puccini, Aurora Pierini, Anna Ientile, Valentina Trifirò, Gianluca Rissmann, Anke Leinonen, Maarit K. Martikainen, Visa Jordan, Sue Thayer, Daniel Scanlon, Ieuan Georgiou, Mary E. Cunnington, Marianne Swertz, Morris Sturkenboom, Miriam Gini, Rosa Clin Pharmacol Ther Research In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project—Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation—with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother‐child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population. John Wiley and Sons Inc. 2021-11-26 2022-01 /pmc/articles/PMC9299060/ /pubmed/34826340 http://dx.doi.org/10.1002/cpt.2476 Text en © 2021 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research
Thurin, Nicolas H.
Pajouheshnia, Romin
Roberto, Giuseppe
Dodd, Caitlin
Hyeraci, Giulia
Bartolini, Claudia
Paoletti, Olga
Nordeng, Hedvig
Wallach‐Kildemoes, Helle
Ehrenstein, Vera
Dudukina, Elena
MacDonald, Thomas
De Paoli, Giorgia
Loane, Maria
Damase‐Michel, Christine
Beau, Anna‐Belle
Droz‐Perroteau, Cécile
Lassalle, Régis
Bergman, Jorieke
Swart, Karin
Schink, Tania
Cavero‐Carbonell, Clara
Barrachina‐Bonet, Laia
Gomez‐Lumbreras, Ainhoa
Giner‐Soriano, Maria
Aragón, María
Neville, Amanda J.
Puccini, Aurora
Pierini, Anna
Ientile, Valentina
Trifirò, Gianluca
Rissmann, Anke
Leinonen, Maarit K.
Martikainen, Visa
Jordan, Sue
Thayer, Daniel
Scanlon, Ieuan
Georgiou, Mary E.
Cunnington, Marianne
Swertz, Morris
Sturkenboom, Miriam
Gini, Rosa
From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
title From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
title_full From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
title_fullStr From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
title_full_unstemmed From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
title_short From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding
title_sort from inception to conception: genesis of a network to support better monitoring and communication of medication safety during pregnancy and breastfeeding
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299060/
https://www.ncbi.nlm.nih.gov/pubmed/34826340
http://dx.doi.org/10.1002/cpt.2476
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